Validation of Pregabalin in Human Plasma by LCMS Method.

ABSTRACT

An accurate and precise developed LCMS method was validated for the determination of pregabalin in human plasma. Validation was carried out according to US FDA guidelines. Validation data showed were within the limits. No matrix effect was found in different sources of human plasma tested. Dilution integrity, Lower limit of quantitation were also within the limit. The Mean extraction recovery of pregabalin was satisfactory.